To compare the outcomes with transcatheter aortic valve implantation (TAVI) versus surgical valve replacement among high-risk patients with severe symptomatic aortic stenosis

The Placement of Aortic Transcatheter Valves (PARTNER) trial Cohort A was a prospective, multicenter, randomized, active-treatment-controlled clinical trial comparing transcatheter aortic-valve replacement with surgical aortic valve replacement in high-risk patients with severe aortic stenosis.

High-risk patient: defined by a Society of Thoracic Surgeons (STS) risk score of 10% or higher or by the presence of coexisting conditions that would be associated with a predicted risk of death by 30 days after surgery of 15% or higher.

Patients were randomly assigned to two groups:

• Surgical aortic valve replacement
• Transcatheter aortic valve implantation (either a transfemoral or a transapical approach)

Study device: The Edwards SAPIEN heart-valve system (Edwards Lifesciences)

The primary endpoint: the rate of death from any cause at 1 year

A total of 699 patients were enrolled at 25 centers. At 30 days, the rates of death from any cause were 3.4% in the transcatheter group compared with 6.5% in the surgical group (P=0.07). At 1 year, the rates of death from any cause were 24.2% in the transcatheter group compared with 26.8% in the surgical group (P=0.44), a reduction of 2.6 percentage point in the transcatheter group (two-sided 95% confidence interval [CI], -9.3 to 4.1; upper limit of the one-sided 95% CI, 3.0 percentage points) was within the prespecified noninferiority margin of 7.5 percentage points (P=0.001 for noninferiority). Rates of all neurologic events (i.e., all strokes and transient ischemic attacks) were higher in the transcatheter group than in the surgical group at 30 days (5.5% vs. 2.4%, P=0.04) and at 1 year (8.3% vs. 4.3%, P=0.04). At 30 days, the rates of major stroke were 3.8% in the transcatheter group and 2.1% in the surgical group P=0.20) At 1 year, the rates of major strokes were 5.1% in the transcatheter group and 2.4% in the surgical group (P=0.07). At 30 days, the transcatheter group had a significantly higher rate of major vascular complications than did the surgical group (11.0% vs. 3.2%, P<0.001) but had lower rates of major bleeding events (9.3% vs. 19.5%, P<0.001) and new-onset atrial fibrillation (8.6% vs. 16.0%), P=0.006). At 30 days, more patients in the transcatheter group had an improvement in cardiac symptoms, but at 1 year there was no significant difference between the two groups.

In high-risk patients with severe aortic stenosis, transcatheter and surgical procedures for aortic valve replacement were associated with similar rates of survival at 1 year and resulted in similar improvements in cardiac symptoms (noninferiority of the transcatheter group, as compared with the surgical group).^[1]